New Arterial Sheath for Stroke and Other Neurovascular Interventions.

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Project Summary/Abstract Stroke, including ischemic stroke, is the 2nd leading cause of death in the world and 5th leading cause of death in the United States. Recent breakthrough advances in device technology have resulted in endovascular stroke treatment becoming the standard of care. However, stroke thrombectomy (intervention) is time sensitive with a window to intervene in less than 16 hours following symptom onset. Patients rarely arrive to the care facility immediately following the onset of symptoms. It is well-known that complications directly increase in proportion to procedure time, specifically 1) a 7.7% decreased probability of functional independence for every hour of stroke onset to successful reperfusion (“time is brain” concept), and 2) sometimes death. In addition, these time sensitive procedures are limited due to tortuous anatomy, prevalent in the elderly (in up to 35%). This in turn also results in higher complication rates and lessens the chance of procedural success. Specifically, neurointerventionalists struggle with difficult anatomy and often are unable to perform these potentially life-saving procedures in 28.9% of patients. Not only is there a delay in reaching the target intracranial artery, but radiation exposure and contrast dose can also rise, placing the patient at additional risk. Therefore, there is a tremendous need for a device to decrease the failure rate and improve the speed of this procedure in difficult tortuous aortic anatomy. RAM Medical Innovations (RAM) has developed a novel carotid sheath that can quickly and safely navigate as well as maintain stable position in this hostile anatomy. RAM's feasibility work showed significantly faster carotid sheath insertion success rate, less endothelial injury, and reduced radiation exposure with our nonlubricious prototype against predicate devices, all of which have an advantageous hydrophilic coating. In this Direct to Phase 2 grant RAM plans to make and test the finalized, lubricious sheath device to demonstrate the product's safety and time efficiency profile. Notably, RAM's device, using a lubricious component found in other FDA approved devices seeks to reduce the potential risk of particle shedding seen with current predicates. In preparation for FDA 510(k) application, Class II device, RAM proposes biocompatibility testing in compliance with the FDA guidelines and ISO protocols. This would include cytotoxicity, sensitization, irritation, systemic toxicity (acute) and hemocompatibility, using in vitro and animal models to establish measurements within acceptable ranges. RAM also plans to perform device sterilization, design verification, packaging and accelerated aging tests that will ensure that the product will perform reliably one-year and two-years post sterilization. Packaging and sterilization testing will also be completed to conform to FDA and ISO standards. Additionally, after each testing process, the device will be functionally tested to ensure that the design is still robust. Successful outcomes in testing and development will result in a new promising tool to deliver stroke treatment efficiently and safely even in patients with difficult aortic anatomy. RAM has obtained third party investments and, after obtaining FDA clearance, intends to partner with or sell the product to a major medical device manufacturer for commercial deployment.